(90 days)
The Mediport 2000 suction device can be generally used in the ENT sector and is equally suitable for both in-patient and outpatient purposes. It can be used for faryngectomy and in the event of heavy secretion in one of the organisms or other operations in the mouth and throut area. The mobile may only be used for the applications listed above.
Mediport 2000 Mobile is a powered suction pump.
Here's an analysis of the provided text, focusing on the request for acceptance criteria and study details.
Limitations of the Provided Text:
The provided text is an FDA 510(k) clearance letter for a medical device called "Mediport 2000 Mobile." This type of document primarily confirms that a new device is "substantially equivalent" to an already legally marketed device (predicate device). It does not generally contain detailed information about specific acceptance criteria or the full study reports that were submitted for the clearance.
Therefore, the following answers are based only on the information that can be inferred or explicitly stated in the provided FDA letter. Many sections will be marked as "Not provided in the document" because the letter's purpose is not to disseminate this level of detail.
Acceptance Criteria and Study for Mediport 2000 Mobile
Summary:
The provided document is an FDA 510(k) clearance letter indicating that the Mediport 2000 Mobile suction device has been found substantially equivalent to a predicate device. This letter signifies regulatory approval for marketing based on a comparison to an existing device, rather than a presentation of direct performance against specific, pre-defined acceptance criteria. The letter itself does not explicitly list the acceptance criteria or a detailed study report.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The 510(k) clearance process relies on demonstrating "substantial equivalence" to a predicate device, which implies meeting similar performance characteristics. Specific performance metrics (e.g., suction pressure, flow rate, reservoir capacity, noise level, reliability) would have been part of the submission but are not detailed in this clearance letter. | Not explicitly stated in the document. The device is cleared for the indicated uses, implying its performance is sufficient for those uses and comparable to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The submission would have included testing data, but its origin (e.g., country, retrospective/prospective nature) is not specified in this clearance letter.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not provided. Given the nature of a powered suction pump, ground truth for performance claims typically comes from engineering and functional testing, not expert clinical interpretation of images or patient outcomes in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
- Not provided. Not applicable in the context of device performance testing for a powered suction pump, which would involve objective measurements rather than subjective expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done?: No. An MRMC study is relevant for diagnostic devices interpreting medical images or data by human readers. A powered suction pump is a therapeutic device, and this type of study would not be applicable.
- Effect Size (AI vs. without AI assistance): Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done?: Not applicable. The Mediport 2000 Mobile is a physical medical device (powered suction pump), not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" does not apply. Performance testing would focus on the physical and functional aspects of the pump.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated, but for a powered suction pump, ground truth would typically be established through objective engineering measurements (e.g., suction pressure achieved, flow rate, vacuum maintenance, reservoir integrity, sterile barrier testing if applicable, electrical safety, biocompatibility of materials). It would not be based on expert consensus, pathology, or outcomes data in the same way a diagnostic device would.
8. Sample Size for the Training Set
- Not applicable. The Mediport 2000 Mobile is a hardware device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.